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Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (fb-PMT) | Experimental | Daily subcutaneous injection of fb-PMT in four escalating cohorts to determine maximum tolerated dose, followed by treatment of up to 10 additional patients at maximum tolerated dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fb-PMT | Drug | Daily dosing based on patient weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Determined by the number of Treatment-Emergent Adverse Events, including Dose-Limiting Toxicities per patient. | 15 months |
| Incidence of Dose Limiting Toxicities [Safety and Tolerability] | Number of participants with a dose-limiting toxicity during the first cycle (28 days) of treatment at their highest dose level administered. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Establishment of Recommended Phase 2 Dose | Maximum Tolerated Dose, as determined by Dose-Limiting Toxicities. | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy L Rodrigues, CCRC | Contact | (203) 260-9632 | amy.rodrigues@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nicholas Blondin, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Hospital | Recruiting | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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3+3 Dose Escalation with option for cohort expansion
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |